Montrium Blog Building a Risk-based TMF Management Framework

The Future of TMF Is Risk-Based In the realm of clinical research, where the pursuit of innovative therapies and patient safety converge, regulatory bodies wield significant influence in shaping the industry’s practices. The call for a risk-based approach in clinical trial management has emerged as a pivotal directive from regulatory authorities, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).